Bacterial Meningitis, Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Haemophilus influenza type b, Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine, Hib, DPT-IPV
Brief summary
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.
Interventions
BIOLOGICALDPT-IPV-Hib
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
BIOLOGICALHib vaccine
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
BIOLOGICALDPT-IPV
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Sponsors
The Research Foundation for Microbial Diseases of Osaka University
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 42 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months) * Written informed consent is obtained from a legal guardian (parent)
Exclusion criteria
* Possibility of anaphylaxis due to food or pharmaceuticals * With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * With experience of Hib, diphteria, pertussis, tetanus or polio vaccination. * Participated in other studies within 12 weeks before obtaining consent * Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment Additional screening criteria check may apply for qualification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 4 weeks after the primary immunization (Visit 4) | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titer of Anti-PRP Antibody | 4weeks after the primary immunization (Visit 4) | — |
| Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the booster dose (Visit 6) | — |
| Geometric Mean Antibody Titer Against Diphtheria Toxin | 4 weeks after the primary immunization (Visit 4) | — |
| Geometric Mean Antibody Titer Against Pertussis | 4 weeks after the primary immunization (Visit 4) | — |
| Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4weeks after the primary immunization (Visit 4) | — |
| Geometric Mean Antibody Titer Against Polio Virus | 4 weeks after the primary immunization (Visit 4) | — |
| Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | 4 weeks after the booster dose (Visit 6) | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8 |
| Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Baseline and 4 weeks after the primary immunization (Visit 6) | — |
| Geometric Mean Antibody Titer Against Tetanus Toxin | 4 weeks after the primary immunization (Visit 4) | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BK1310 DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 133 |
| ActHIB® and Tetrabik (Control) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 133 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by parent/guardian | 0 | 2 |
Baseline characteristics
| Characteristic | BK1310 | ActHIB® and Tetrabik (Control) | Total |
|---|---|---|---|
| Age, Customized >=2 and <3 months | 124 Participants | 125 Participants | 249 Participants |
| Age, Customized >=3 months | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 133 Participants | 133 Participants | 266 Participants |
| Sex: Female, Male Female | 73 Participants | 62 Participants | 135 Participants |
| Sex: Female, Male Male | 60 Participants | 71 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 133 | 0 / 134 |
| other Total, other adverse events | 131 / 133 | 132 / 134 |
| serious Total, serious adverse events | 9 / 133 | 11 / 134 |
Outcome results
Primary
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 99.2 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 88.7 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 99.2 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 98.5 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 100.0 percentage of participants |
Secondary
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1). For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (tetanus: n=1, polio serotype1,2 and 3: n=1 each).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （FHA） | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （FHA） | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against tetanus toxin | 99.2 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .~For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .~For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 98.5 percentage of participants |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 2524.05 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 8821.88 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 6439.23 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 2662.91 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 7512.10 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 7355.96 fold change |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.841 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.283 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .~For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Diphtheria Toxin | 9.766 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Diphtheria Toxin | 8.961 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 155.30 EU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 56.48 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 200.24 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 85.24 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .~For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis | Geometric mean antibody titer against pertussis （PT） | 209.05 EU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Pertussis | Geometric mean antibody titer against pertussis （FHA） | 144.73 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis | Geometric mean antibody titer against pertussis （PT） | 279.62 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis | Geometric mean antibody titer against pertussis （FHA） | 221.34 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Polio Virus
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 684.95 IU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 2026.44 IU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 1729.00 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 663.98 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 1767.97 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 2075.06 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (n=1).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.904 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.598 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.473 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.158 IU/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer of Anti-PRP Antibody | 23.688 µg/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer of Anti-PRP Antibody | 6.698 µg/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .~For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer of Anti-PRP Antibody | 56.545 µg/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer of Anti-PRP Antibody | 34.246 µg/mL |